Hutchison China MediTech (Chi-Med) has commenced a Phase I/Ib clinical trial for the treatment of relapsed or refractory lymphoma patients using its investigational drug candidate HMPL-523.
HMPL-523 is an oral, selective, small-molecule inhibitor of spleen tyrosine kinase, which is known to play a key role in B-cell receptor signalling and is a therapeutic target in different B-cell lymphoma subtypes.
The new international, open-label, two-stage trial will assess the safety, preliminary efficacy and tolerability of the drug candidate in around 80 participants suffering from relapsed or refractory lymphoma.
Chi-Med is conducting the study at multiple sites in the US and Europe. The first patient was dosed last month in the US.
The trial comprises dose escalation and expansion phases and will track primary outcome measures as adverse events determined using the National Cancer Institute Common Terminology Criteria for Adverse Events.
Secondary outcome measures include maximum plasma concentration and area under the concentration-time curve to determine HMPL-523’s pharmacokinetic properties, as well as objective response rate (ORR) for the drug candidate’s anti-tumour activity.
The Phase I/Ib trial is set to be completed in December 2022.
Chi-Med added that the study is designed to support HMPL-523’s Phase Ib dose-expansion programme being conducted across a variety of haematological cancers in Australia and China.
The drug candidate is also being developed for treating immune thrombocytopenia (ITP) in a Phase I trial in China.
Last month, Chi-Med began a separate Phase I/Ib trial for advanced relapsed or refractory lymphoma treatment with its isoform phosphoinositide-3 kinase delta (PI3Kδ) inhibitor, HMPL-689.
This trial will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral HMPL-689 in approximately 85 patients.